Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly identifies this as an FDA Class I recall, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the FLOW-i Anesthesia System, a medical device intended for administering inhalation anesthesia to neonatal and adult patients. The recall involves 1,641 units distributed worldwide, including in the United States and numerous international countries.
The recall is due to a defect where the patient cassette can become dislodged. This dislodgement can result in gas leakage within the system's internal circuit, which may lead to a stop in ventilation for the patient.
Healthcare providers should contact Maquet Cardiovascular for instructions on how to address the defect. The recall is classified as Class I by the FDA, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
Distribution
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